Trial record 93 of 408 for: ARIPIPRAZOLE

Previous Study | Return to List | Next Study

Aripiprazole Used as Dual Therapy in the Treatement of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00325689

Recruitment Status : Completed

First Posted : May 15, 2006

Last Update Posted : November 8, 2013

Sponsor:

Collaborator:

Otsuka America Pharmaceutical

Information provided by:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Description

Brief Summary:

A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic treatment.

Condition or disease	Intervention/treatment	Phase
Schizophrenia Schizoaffective Disorder	Drug: Quetiapine or Risperidone + Aripiprazole Drug: Quetiapine or Risperidone + placebo	Phase 4

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	323 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Multicenter, Randomized, Double-blind, Placebo-controlled, 16 Week Study of Aripiprazole Used as Dual Therapy in the Treatment of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating an Inadequate Response to Quetiapine or Risperidone Monotherapy.
Study Start Date :	July 2006
Actual Primary Completion Date :	October 2007
Actual Study Completion Date :	October 2007

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Schizoaffective disorder Schizophrenia

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Quetiapine Quetiapine fumarate Aripiprazole

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Quetiapine or Risperidone + Aripiprazole	Drug: Quetiapine or Risperidone + Aripiprazole Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Aripiprazole 2-15 mg/day, Flexible, 16 weeks. Other Name: Abilify
Placebo Comparator: Quetiapine or Risperidone + placebo	Drug: Quetiapine or Risperidone + placebo Tablets, Oral, Quetiapine 400-800 mg/day or Risperidone (4-8 mg/day) + Placebo, Flexible, 16 weeks.

Outcome Measures

Primary Outcome Measures :

Evaluate the efficacy of adding Aripiprazole to atypical antipsychotic treatment via Positive and Negative Symptoms Scale (PANSS) score at endpoint [ Time Frame: (Week 16) or at time of discontinuation ]

Secondary Outcome Measures :

Assess efficacy according to changes in the severity of illness symptoms as measured by the Clinical Global Impressions-Severity (CGI-S) [ Time Frame: at endpoint (Week 16) ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder
Stable symptoms and dose of Quetiapine or Risperidone

Exclusion Criteria:

First diagnosis in the past year
Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325689

Show 48 Study Locations

Sponsors and Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.

Otsuka America Pharmaceutical

Investigators

Layout table for investigator information

Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

Publications:

Kane JM, Correll CU, Goff DC, Kirkpatrick B, Marder SR, Vester-Blokland E, Sun W, Carson WH, Pikalov A, Assunção-Talbott S. A multicenter, randomized, double-blind, placebo-controlled, 16-week study of adjunctive aripiprazole for schizophrenia or schizoaffective disorder inadequately treated with quetiapine or risperidone monotherapy. J Clin Psychiatry. 2009 Oct;70(10):1348-57. doi: 10.4088/JCP.09m05154yel.

Layout table for additonal information

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00325689 History of Changes
Other Study ID Numbers:	CN138-397 ST
First Posted:	May 15, 2006 Key Record Dates
Last Update Posted:	November 8, 2013
Last Verified:	April 2011

Additional relevant MeSH terms:

Layout table for MeSH terms

Aripiprazole Schizophrenia Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Risperidone Quetiapine Fumarate Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs	Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Antidepressive Agents Dopamine Agonists Serotonin 5-HT1 Receptor Agonists Serotonin Receptor Agonists Serotonin 5-HT2 Receptor Antagonists Dopamine D2 Receptor Antagonists

To Top